Description:
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Alexion, AstraZeneca Rare Disease’s Central Quality Systems and Compliance (CQSC) unit is looking for an Associate Director of Quality Systems to join our team. CQSC partners with internal stakeholders across Alexion Quality, Commercial, IT, Operations and Supply Chain to deliver an effective & compliant quality system for drugs and devices.
In this role, the successful candidate will lead diverse quality systems initiatives with the objectives of evolving Alexion’s global quality management system and empowering our business partners to leverage quality as a strategic enabler.
- Lead implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve Alexion’s strategic Quality priorities.
- Sustain and improve QMS compliance in Change Control and other areas of assigned focus.
- Provide tactical and operational support to the Global Change Control Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development.
- Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure and monitoring of change controls.
- Identify, assess, communicate, manage, and mitigate quality system risks.
- Lead Change Control Review Boards (CCRBs) and drive CCRB improvement and standardization globally.
- Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
- Represent CQSC function on business development and integration projects.
- Create and update procedural documentation and work instructions with accuracy and clarity.
- Support GMP and GDP audits and inspections.
- Liaise with external consortia to keep abreast of industry trends and benchmarking.
- Creates and environment supportive of Alexion RDU’s Quality Culture and Values.
- Serve as delegate to Director, Quality Systems as required.
- Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
- Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
- Knowledge of global GxP requirements for quality systems, drugs, and devices.
- Direct prior experience with planning, ownership, and quality oversight of change controls.
- Excellent written and verbal skills and strong interpersonal skills
- Experience managing global projects with team members in multiple locations
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Lean Green Belt or Black Belt certification preferred.
- ASQ Auditor certification or equivalent certification/experience.
- Knowledge of Veeva Vault Quality, Microsoft PowerBI and TrackWise